Efficacy of Probiotics (LiveSpo Navax) in Preventing Respiratory Diseases in Children
Sponsor: ANABIO R&D Ltd. Company
AI Summary
First randomised controlled trial demonstrating safety and efficacy of a nasal spray Bacillus spore probiotic (LiveSpo Navax) for preventing upper respiratory tract infections in preschool children aged 2–6. Published results (Scientific Reports) showed 1–2 day faster recovery, 26-fold viral load reduction, 65-fold bacterial reduction, and 100% recovery in treated groups vs 12.5–25% still symptomatic in controls.
Trial Details
| Condition | upper respiratory tract infection, respiratory disease, viral respiratory infection |
| Intervention | LiveSpo Navax nasal/throat spray (1 billion CFU/mL B. subtilis and B. clausii) or LiveSpo Navax Kid (0.6 billion CFU/mL), 2 sprays each nostril + 2 throat sprays, twice daily for 4 weeks |
| Comparator | 0.9% normal saline spray, same regimen |
| Phase | Not Applicable |
| Status | completed |
| Participants | 600 |
| First Registered | 7 May 2025 |
| Lead Investigator | Spobiotic Research Center / ANABIO R&D Ltd. Company / Hanoi Medical University |
Primary Outcome
Reduction in respiratory infection incidence, duration of illness, viral and bacterial pathogen loads at study completion
Secondary Outcomes
Symptom severity scores
Medication usage and antibiotic prescription rates
School absenteeism
Safety and tolerability
Trial Sites
Countries
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